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NCT00638690 · ADVERSE EVENTS

Adverse events

Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy · Source last updated 2014-04-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
5 years
Other-event reporting threshold
5%

Following interim analysis of the study by the Independent Data Monitoring Committee in August 2010, the protocol was amended to provide for the unblinding of all study participants and the option for placebo participants to receive abiraterone acetate treatment; 67 placebo participants crossed over.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Abiraterone Acetate

Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.

365 / 791766 / 791Not reported / Not reported
Placebo

Placebo plus prednisone/prednisolone

175 / 394381 / 394Not reported / Not reported
Placebo to Abiraterone Acetate

Placebo plus prednisone/prednisolone crossed over to abiraterone acetate plus prednisone/prednisolone

29 / 6757 / 67Not reported / Not reported

Group identifiers: EG000: Abiraterone Acetate · EG001: Placebo · EG002: Placebo to Abiraterone Acetate

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      67
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      67
    term
    Coagulopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      67
    term
    Pancytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      67
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      67
    term
    Bradycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      67
    term
    Hypoacusis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      67
    term
    Tinnitus
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      67
    term
    Vertigo
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      67
    term
    Hyperglycaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      67
    term
    Blindness
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      67
    term
    Cataract
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      67
    term
    Diplopia

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      202
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      67
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      236
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      124
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      67
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      166
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      67
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      67
    term
    Dyspepsia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      272
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      132
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      67
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      204
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      97
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      67
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      87
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      67
    term
    Pyrexia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      67
    term
    Nasopharyngitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      70
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      67
    term
    Contusion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      155
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      74
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      67
    term
    Anorexia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      67
    term
    Hyperglycaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      149
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      67
    term
    Hypokalaemia
Complete source fields
description
Following interim analysis of the study by the Independent Data Monitoring Committee in August 2010, the protocol was amended to provide for the unblinding of all study participants and the option for placebo participants to receive abiraterone acetate treatment; 67 placebo participants crossed over.
event Groups
  1. description
    Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
    id
    EG000
    other Num Affected
    766
    other Num At Risk
    791
    serious Num Affected
    365
    serious Num At Risk
    791
    title
    Abiraterone Acetate
  2. description
    Placebo plus prednisone/prednisolone
    id
    EG001
    other Num Affected
    381
    other Num At Risk
    394
    serious Num Affected
    175
    serious Num At Risk
    394
    title
    Placebo
  3. description
    Placebo plus prednisone/prednisolone crossed over to abiraterone acetate plus prednisone/prednisolone
    id
    EG002
    other Num Affected
    57
    other Num At Risk
    67
    serious Num Affected
    29
    serious Num At Risk
    67
    title
    Placebo to Abiraterone Acetate
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      202
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      67
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      236
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      124
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      67
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      166
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      67
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      67
    term
    Dyspepsia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      272
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      132
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      67
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      204
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      97
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      67
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      87
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      67
    term
    Pyrexia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      67
    term
    Nasopharyngitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      70
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      67
    term
    Contusion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      155
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      74
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      67
    term
    Anorexia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      67
    term
    Hyperglycaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      149
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      67
    term
    Hypokalaemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      67
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      67
    term
    Coagulopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      67
    term
    Pancytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      67
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      67
    term
    Bradycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      67
    term
    Hypoacusis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      67
    term
    Tinnitus
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      67
    term
    Vertigo
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      67
    term
    Hyperglycaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      67
    term
    Blindness
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      67
    term
    Cataract
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      791
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      67
    term
    Diplopia
time Frame
5 years

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice